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This page lists veterinary biologics information published in the last 90 days.

CVB Draft Guidance Documents for Comment

Title ID

Comments Due

Date

Posted

Date

Veterinary Services Memorandum 800.121

Autologous Therapeutic Biologics

DT

106580

extended to April

22, 2024

March 4,

2024

CVB Notices

Title ID

Publication

Date

Posted

Date

Issuance of Licenses (260.93 KB) 23-

14

January 24,

2024

February

6, 2024

Issuance of a Conditional License for Rabbit

Hemorrhagic Disease Virus (277.99 KB)

23-

15

January 24,

2024

February

6, 2024

Request Input on Proposed Enhancement for Export

Certification (292.26 KB)

24-

01

January 24,

2024

February

6, 2024

Issuance of Licenses (304.67 KB) 24-

02

February 4,

2024

February

6, 2024

Veterinary Vaccines and Veterinary Diagnostic

Products Targeting Avian Metapneumovirus (all

subtypes) (129.43 KB)

24-

03

February 5,

2024

February

6, 2024
Title ID

Publication

Date

Posted

Date

Posting of Selected Center for Veterinary Biologics

Notices and Veterinary Services Memoranda on the

CVB Web Pages for Comment

24-

04

March 14,

2024

March 20,

2024

Availability of a Pilot Project to Implement a Focused

Review Option for Review of Outlines of Production

Submitted Through the NCAH Portal

24-

05

March 13,

2024

March 20,

2024

Veterinary Services Memoranda (new or revised)

Title ID

Publication

Date

Posted

Date

Basic Licensing Requirements and Guidelines

for Diagnostic Products 800.73

January 17,

2024

March 22,

2024

Rulemaking

There are no newly published documents at this time.

Proposed Rulemaking

There are no newly published documents at this time.

Notices of Availability

There are no newly published documents at this time.

Supplemental Assay Methods

Title ID

Document

Date

Posted Date

Potency Testing Clostridium perfringens Type C

Beta Antigen 201

August 24,

2023

December

27, 2023

Potency Testing Clostridium perfringens Type D

Epsilon Antigen 203

August 24,

2023

December

27, 2023

Potency Testing Clostridium novyi Type B Alpha

Antigen 207

August 10,

2023

December

27, 2023

Potency Testing Clostridium sordellii Antigen 212

August 10,

2023

December

27, 2023
Title ID

Document

Date

Posted Date

Sterility Testing of Preparations Other Than Live

Vaccines 906 May 12, 2023

December

27, 2023

Sterility Testing of Live Viral Vaccines and Master

Seed Virus Samples 908 May 12, 2023

December

27, 2023

Sterility Testing of Live Viral Vaccines of Chicken

Embryo Origin Recommended for Nonparenteral

Injection

909 May 12, 2023

December

27, 2023

Titration of Pseudorabies Virus in Vaccines 118

August 7,

2023

February 20,

2024

Titration of Pseudorabies Virus Neutralizing

Antibody (Constant Virus-Varying Serum Method) 119

August 7,

2023

February 20,

2024

Titration of Neutralizing Antibody 300

August 22,

2023

February 20,

2024

Titration of Neutralizing Antibody - Canine

Distemper 301

August 22,

2023

February 20,

2024

Detection of Extraneous Hemadsorbing Agents in

Master Seed Virus 313

August 23,

2023

February 20,

2024

Testing Protocols

Title ID Document Date Posted Date

Standard Bacterial Plate Count CVB-SOP-0104 March 15, 2024 March 22, 2024

Reagent Data Sheets

Title Lot ID

Publication

Date

Posted

Date

Mycoplasma synoviae 17Apr12-

MS

November 22,

2023

January 18,

2024

Mycoplasma orale 18Apr12

November 22,

2023

January 18,

2024

Mycoplasma hyorhinis 16Apr12

November 22,

2023

January 18,

2024

Secondary Reference Serum-Bovine IgG;

Stock for Bovine IgG Species Standard 10848

November 22,

2023

January 18,

2024
Title Lot ID

Publication

Date

Posted

Date

Secondary Reference Serum-Equine IgG;

Stock for Equine IgG Species Standard 10849

November 22,

2023

January 18,

2024

Clostridium perfringens Type D (epsilon)

Antitoxin IRP 249

November 22,

2023

January 18,

2024

Clostridium tetani Antitoxin 5.0 AU/mL

(guinea pig origin) IRP 466

December 8,

2023

January 18,

2024

Clostridium chauvoei Flagella-specific

(7D11/YD7) Monoclonal Antibody (MAb) IRP 608

December 7,

2023

January 18,

2024

Clostridium perfringens type C (beta) toxin IRP 624

December 8,

2023

January 18,

2024

Clostridium perfringens Type C (beta)

Antitoxin IRP 637

December 8,

2023

January 18,

2024

Clostridium novyi Type B Toxin IRP 636

December 8,

2023

January 18,

2024

Clostridium septicum Antitoxin IRP 687

December 8,

2023

January 18,

2024

Escherichia coli Anti-F41 Pilus Polyclonal

Antibody (F41 PAb) IRP 693

December 8,

2023

January 18,

2024

Clostridium perfringens Type D (epsilon)

Antitoxin IRP 249

February 28,

2024

March 11,

2024

Clostridium novyi Type B (alpha) Antitoxin IRP 507

(04)

February 28,

2024

March 11,

2024

Clostridium sordellii antitoxin IRP 501

(04)

February 28,

2024

March 11,

2024

Clostridium perfringens type C (beta) toxin IRP 624

February 29,

2024

March 11,

2024

Clostridium chauvoei Spore Preparation IRP 631

February 28,

2024

March 11,

2024

Clostridium novyi Type B Toxin IRP 636

February 28,

2024

March 11,

2024

Clostridium sordellii Toxin IRP 675

February 28,

2024

March 11,

2024
Title Lot ID

Publication

Date

Posted

Date

Clostridium perfringens type D (epsilon)

toxin IRP 632

February 27,

2024

March 12,

2024

Other

Title ID

Publication

Date

Posted

Date

Organizational Chart: CVB Management DB-3

November

19, 2023

December

27, 2023

Organizational Chart: Assistant Director DB-4

November

19, 2023

December

27, 2023

Organizational Chart: Inspection and Compliance DB-4

December 3,

2023

December

27, 2023

Policy, Evaluation and Licensing Reviewer Manual:

Precedents for International Label Noncompliance

CVBWI0183

December

12, 2023

January 18,

2024

Current Veterinary Biologics Product Catalog January 10,

2024

February

20, 2024

Inspection and Compliance Manual Chapter: Log

APHIS Form 2008

CVBWI0163

January 9,

2024

February

20, 2024

Inspection and Compliance Manual Chapter:

Conditional Serial Release

CVBWI0151

July 20, 2020 February

20, 2024

Inspection and Compliance Manual Chapter:

Inspection Tools – Requested Documents and

Observations

CVBWI0074

December

21, 2023

February

20, 2024

Inspection and Compliance Manual Chapter:

Investigation Procedures Following a Report of a

Disease Outbreak in an SPF Flock Which Supplies

SPF Eggs or Chickens for Use in Vaccine

Production

CVBWI0122

December

21, 2023

February

20, 2024
Title ID

Publication

Date

Posted

Date

Historical Summary Report of CVB Policy

Management for: 9 CFR Regulation/CVB Public

Notice/CVB Routine Notice/Veterinary Services

Memorandum

February 1,

2024

February

22, 2024

Organizational Chart: Safety and Security Unit DB-8

February 25,

2024

March 12,

2024

Organizational Chart: Policy, Evaluation and

Licensing DB-9

February 16,

2024

March 20,

2024

NCAH Portal User Guide: Logging In and IT

Security Awareness Training 1

March 20,

2024

March 22,

2024

NCAH Portal User Guide: Qualifications of

Veterinary Biologics Personnel 4

March 22,

2024

March 22,

2024

NCAH Portal User Guide: Submitting Labels to

CVB-Policy, Evaluation and Licensing 11

March 22,

2024

March 22,

2024

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